Behçet Disease
Conditions
Keywords
dusquetide
Brief summary
This is a clinical study to see if dusquetide can treat flares of oral and genital ulcers caused by Behcet's Disease. Study participants will receive an infusion of dusquetide twice a week for 4 weeks (8 treatments total), with weekly follow-up visits for an additional 4 weeks.
Interventions
DRUGDusquetide
1.5 mg/mL dusquetide administered as a 4 minute IV infusion, twice per week for 4 weeks
Sponsors
Soligenix
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participants must have a clinical diagnosis of Behcet's Disease meeting the International Study Group criteria. * Participants must have at least two oral ulcers and/or one genital ulcer on the day of randomization. * Participants willing to follow the clinical protocol and voluntarily give their written informed consent. * Female participants not pregnant or nursing and willing to undergo a pregnancy test prior to treatment initiation and at the end of the treatment period.
Exclusion criteria
* Pregnancy or mothers who are breast-feeding. * All women of childbearing potential (WOCBP) and males with female partners who are WOCBP not willing to agree to the use of effective contraception during the trial. * Evidence of significant renal, hepatic, hematologic or immunologic disease. * Use of any investigational medication within 4 weeks prior to enrollment or 5 pharmacokinetic/pharmacodynamic half-lives (whichever is longer). * Having received concomitant immune modulating therapy (except colchicine) within: 1. Ten days prior to enrollment for azathioprine and mycophenolate mofetil, 2. Four weeks (28 days) prior to enrollment for cyclosporine, methotrexate, cyclophosphamide, thalidomide and dapsone 3. Oral and topical corticosteroids must have been tapered as appropriate and discontinued 3 days prior to day of enrollment 4. At least 5 terminal half-lives for all biologics including, but not limited to, those listed below; within: i. Four weeks prior to enrollment for etanercept; ii. Eight weeks prior to enrollment for infliximab; iii. Ten weeks prior to enrollment for adalimumab, golimumab, certolizumab, abatacept, and tocilizumab; iv. Six months prior to enrollment for secukinumab. * Having received oral or parenteral corticosteroids within 6 weeks (42 days) prior to enrollment. * Having received apremilast (Otezla) within 4 weeks prior to enrollment. * Presence of non- Behcet's Disease related genital ulcers, including both infectious and non-infectious etiologies. * Active organ involvement requiring immunosuppressive treatment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Oral Ulcers | 4 weeks | The number of oral ulcers were counted at baseline and each visit during the treatment period. |
| Number of Genital Ulcers | 4 weeks | The number of genital ulcers will be counted at baseline and each visit during the treatment period. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pain of Oral Ulcers From Baseline to End of Treatment | 4 weeks | The pain of oral ulcers was measured using a 100 mm Visual Analog Scale (VAS) at baseline and each visit during the treatment period. The minimum score is 0 mm (no pain) and the maximum score is 100 mm (maximum pain). The change in pain is the difference between the score at baseline and the score at the end of treatment, where a negative value indicates a reduction in pain. |
| Change in Pain of Genital Ulcers From Baseline to End of Treatment | 4 weeks | The pain of genital ulcers was measured using a 100 mm Visual Analog Scale (VAS) at baseline and each visit during the treatment period. The minimum score is 0 mm (no pain) and the maximum score is 100 mm (maximum pain). The change in pain is the difference between the score at baseline and the score at the end of treatment, where a negative value indicates a reduction in pain. |
Countries
Turkey (Türkiye)
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 43 years STANDARD_DEVIATION 12.2 |
| Race/Ethnicity, Customized Caucasian | 8 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 8 Participants |
| Region of Enrollment Turkey | 8 Participants |
| Sex: Female, Male Female | 6 Participants |
| Sex: Female, Male Male | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 8 |
| other Total, other adverse events | 7 / 8 |
| serious Total, serious adverse events | 0 / 8 |
Outcome results
None listed